External Data Management Specialist

1217 MSD Polska sp.z.o.o.; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

MSD is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author and maintain transfer specifications, and coordinate with service providers/IT for accurate ingestion. You will ensure data completeness, reconciliation, traceability, and compliance with ICH‑GCP.

The role emphasizes collaboration with GDMS and cross‑functional teams to drive quality and timely delivery.

Qualifications

• 4+ years of experience in data management, clinical trial operations, or a related field.
• Experience with trial data standards and data quality processes.
• Ability to interpret mapping rules and review load logs.
• Experience supporting audits and CAPA activities.

Responsibilities

• Gather external data requirements from protocols, service providers, and study stakeholders.
• Develop external data specifications in accordance with standards, obtaining required stakeholder approvals.
• Execute test and first-production file reviews to confirm adherence to approved external data specifications.
• Monitor external data file loads, review error logs, and resolve or escalate issues.

Skills

Clinical data management

Data quality assurance

Stakeholder communication

Audit readiness

Education

Bachelor's degree in Life Sciences or IT

Master's degree preferred

Tools

EDC systems

eCOA

CDISC SDTM

Clinical data standards

Job description

Job Description

The External Data Management (EDM) Specialist supports teams in execution of trial-level external-data activities, authoring and maintaining transfer specifications and coordinating with service providers/IT for accurate ingestion. The role performs completeness, reconciliation, and traceability checks, applies standards and controlled terminology, and supports audit/inspection preparation and targeted process improvements.

Responsibilities

Gather external data requirements from protocols, service providers, and study stakeholders. Develop external data specifications in accordance with standards, obtaining required stakeholder approvals. Execute test and first-production file reviews to confirm adherence to approved external data specifications. Monitor external data file loads, review error logs, and resolve or escaletc. Support Specimen Lifecycle Management reconciliation and external data validation to ensure data are review‑and‑lock‑ready for CDM (Clinical Data Management). Participate in service provider governance forums (e.g., kick‑off and status meetings). Monitor service provider KPIs, metrics, and timelines; identify and communicate risks to study leads. Support our company’s Research Laboratory Quality Assurance in service provider qualification activities, audits, and CAPA resolution as required. Provide status updates on assigned checks and reconciliations in internal and external team meetings. Act as a reliable partner to GDMS (Global Data Management & Standards) and cross‑functional teams, aligning on priorities and closing feedback loops to support coordinated delivery. Proactively support the CDM Trial Lead in trial data quality oversight and risk identification. Support additional projects and continuous improvement initiatives as assigned, including (but not limited to) process, standards, and platform / tool efforts. Archive and maintain required external data documentation in the eTMF (electronic Trial Master File) per SOPs (Standard Operating Procedures), including service provider correspondence, mapping specifications, and transfer logs. Maintain compliance with SOPs, ICH‑GCP (International Council for Harmonization - Good Clinical Practice), and protocol‑specific requirements to ensure inspection readiness.

Required Technical Skills

Working understanding of the clinical development process and end-to-end trial data flow. Working knowledge of clinical trial data structures and tools, including electronic data capture (EDC) and other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) as well as associated utilities for managing, extracting, and reporting data. Able to interpret mapping rules, review load logs, and recognize common data‑integration defect patterns. Basic knowledge of standards‑library processes and working experience applying CDISC [Clinical Data Interchange Standards Consortium] (SDTM [Study Data Tabulation Model], CDASH [Clinical Data Acquisition Standards Harmonization]) and controlled vocabularies (e.g., LOINC [Logical Observation Identifiers Names and Codes])

Required Non-Technical Skills

Communicates effectively (oral/written) with technical and business partners and electronic data providers; adapts style to audience. Collaborates effectively across functions; facilitates small working sessions and follows through on action items. Works independently with minimal guidance; proactively identifies risks and proposes options. Manages multiple tasks and priorities while maintaining focus on the critical path. Uses data and basic structured thinking to triage issues, document assumptions and decisions, and escal...

Required Enterprise Leadership Skills

Networking & Partnerships | Develops effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals. Executional Excellence | Takes timely action to accomplish work goals in line with compliance standards, while demonstrating initiative and a proactive approach to achieving results. Ownership & Accountability | Takes ownership of assignments, maintains high standards for quality and performance, and is accountable for completing work effectively and reliably.

Candidates must meet one of the following qualifications

4+ years of experience in data management, clinical trial operations, or a related field; or Associate's degree in any field and 3+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or Bachelor's degree in any field and 2+ years of experience in data management, clinical trial operations, or a related field. Degrees in Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology, or related disciplines are preferred; or Master’s degree or Doctorate in any field, preferably Nursing, Pharmacy, Life Sciences, Allied Health, Information Technology, Data Science, Medical Technology, or a related discipline.

Additional location(s) Compensation Information

Required Skills: Clinical Data, Clinical Databases, Clinical Data Management, English Language, Services Management, Vendor Management

Job Posting End Date

11/9/2026

About our company

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.